Hans van den Heuvel

10 increase or less in the telemonitoring group. With a one sided α of 0.05, the study will achieve a power (β) of more than 0.80 if 200 women will be included in each trial arm (400 women in total). The sample size was calculated for non-inferiority testing with the one-sided Score test (Farrington & Manning) using PASS software. Data handling, analysis and result reporting At study entry, baseline data like patient demographics, medical and obstetric history and current pregnancy details are collected. At delivery relevant data will be collected for the assessment of perinatal outcomes such as gestational age at birth, birth weight, condition at birth (Apgar scores, umbilical cord blood gas analysis), neonatal admission (type of ward and number of days). Neonatal mortality and morbidity will be specified. For the mother, data will be collected on treatment for pain relief, mode of delivery and adverse outcomes (eclampsia, thromboembolic events and HELLP syndrome). Standardized online case record forms developed by Julius Centre for Research Support (UMC Utrecht) are used, including source data verification options. Missing data will be handled according to the complete- case analysis principle, based on the availability of the components needed to determine the primary endpoint. Primary outcome Data analyses will primarily be carried out according to the intention-to-treat principle, i.e. the participants will be analysed according to their randomized allocation, regardless of the actual interventions received by the patient. Results will be reported according to CONSORT guidelines, using the extension for non-inferiority trials. If necessary, skewed continuous variables will be transformed to normality prior to the analyses. Supplementary, we will perform per protocol analyses excluding participants in whom there is a clear deviation or suboptimal execution of the intended care as prescribed by the protocol in either the admission group or the telemonitoring group. Examples include technical difficulties at home or non-compliance of study agreements, cross-over, or participants in the telemonitoring arm with (multiple) hospital admissions accounting for over half of the study period. The primary outcome, the composite (dichotomous) endpoint of perinatal mortality and morbidity will be analysed with logistic regression analysis with the stratification factors (centre of inclusion and diagnosis of pregnancy complication) and parity as pre-defined covariates in the regression model. No pre-specified subgroup analyses are planned. Secondary outcomes Each individual component outcome within the composite outcome will be reported as a single (secondary) outcome to provide further insight as the incidence and the relative importance between components of the composite outcome differ. Point estimates with confidence intervals for the comparison of groups will be reported for these components of the composite outcome. HOTEL TRIAL STUDY PROTOCOL 171